WHO ICTRP trial
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE…
PER-037-18 · Registro Peruano de Ensayos Clínicos (REPEC) · Not Recruiting
Key facts
| Trial ID | PER-037-18 |
|---|---|
| Public title | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF CEFEPIME- AAI101 COMPARED TO PIPERACILLIN/TAZOBACTAM IN THE TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS, INCLUDING ACUTE PYELONEPHRITIS, IN ADULTS |
| Scientific title | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF CEFEPIME- AAI101 COMPARED TO PIPERACILLIN/TAZOBACTAM IN THE TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS, INCLUDING ACUTE PYELONEPHRITIS, IN ADULTS |
| Primary sponsor | Allecra Therapeutics SAS, |
| Registry | Registro Peruano de Ensayos Clínicos (REPEC) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | III |
| Countries | Bulgaria;Estonia;Poland;Ukraine;United States |
| Conditions | -N390 Urinary tract infection, site not specified Urinary tract infection, site not specified;N390;Urinary tract infection, site not specified |
| Interventions | Group name:2 g cefepime plus 500 mg AAI101 Type of group;1 N° of participants:42 Intervention(s) description:Following randomization, patients will receive: -2 g cefepime plus 500 mg AAI101 infused over a period of 2 hours every 8 hours… |
| Registration date | Jun 11, 2018 |
| Target size | 42 |
| Secondary IDs | 2017-004868-35 |
| Registry page | ins.gob.pe |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: